Impact of Lifestyle on Health Maintenance: A Randomized Controlled Trial (LifeHealth-RCT)

University of Zadar

Status: Begins enrollment in 6 months

Conditions: Emotional Eating Behaviour; Inactivity/Low Levels of Exercise; Obesity & Overweight; Sleep Disorder; Unhealthy Alcohol Use; Unhealthy Diet; Smoking Behaviors; Anxiety; Depressed Mood; Metabolic Syndrome; Stress

Treatments: Behavioral: Mediterranean Diet Education; Behavioral: Stress-Resilience Training; Behavioral: Intervention of physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT07314957

EU Next Generation NPOO (Other Grant/Funding Number)

IP UNIZD 2025-27040

Details and patient eligibility

About

This study aims to evaluate the impact of public health interventions on changes in healthy lifestyle habits over time and their subsequent effects on health outcomes. The investigators hypothesize that exposing at-risk populations to structured physical activity programs, education on healthy nutrition, promotion of the Mediterranean diet, and workshops focused on strengthening psychological resilience will lead to improvements in anthropometric, oxidative, metabolic, and psychological parameters. Anthropometric and laboratory measures will be collected at multiple time points throughout the study. The longitudinal follow-up will span 12 months. It is anticipated that sustained adherence to healthy lifestyle behaviors will result in positive lifestyle changes and enhanced health-related quality of life.

Full description

Contemporary lifestyle patterns are characterized by a fast pace of life, exposure to stressful stimuli, and unhealthy habits. Physically inactive adults who are exposed to stress, smoke, and have poor dietary habits are at increased risk of developing metabolic syndrome, oxidative stress, overweight, hormonal imbalance, insulin resistance, impaired mental health, and lower health-related quality of life.

Studies confirm that lifestyle is one of the most influential modifiable factors in disease development. This study aims to evaluate whether a structured lifestyle intervention, including supervised physical exercise, adherence to a healthy diet, and stress-resilience training, can improve metabolic health, reduce oxidative stress, and enhance mental health and quality of life in adults with overweight, compared to a control group receiving standard lifestyle advice. Participants will be randomly assigned to one of four groups: supervised exercise group, Mediterranean diet education group, stress-resilience and support group and control group receiving standard lifestyle recommendations. Participants in the experimental groups will engage in regular physical activity, follow a Mediterranean diet, participate in psychological resilience-building workshops and support groups, and attend weekly individual and group sessions, followed by a 12-month follow-up period.

The study will assess anthropometric measures (body weight, waist and hip circumference), metabolic parameters (blood glucose, HbA1c, cholesterol, HOMA-IR), oxidative stress markers (AGEs), hormonal responses (cortisol, thyroid hormones), mental health, perceived stress, and quality of life. Participants will wear smart bracelets to monitor daily activity, steps, heart rate, and sleep. Measurements will be taken at baseline, immediately after the 12-week intervention (3 month), and during follow-up at 6, and 12 months.

The investigators hypothesize that the structured lifestyle intervention combining physical activity, Mediterranean diet education, and stress-resilience training will lead to significant improvements in metabolic, oxidative, and psychological health outcomes compared to standard lifestyle advice.

The scientific findings gained from this study may significantly contribute to understanding the effectiveness of lifestyle interventions in preventing chronic diseases associated with unhealthy lifestyles. The findings from this study are expected to provide insights into effective lifestyle interventions for at-risk populations, ultimately benefiting both individuals and communities. These interventions can improve the effectiveness of programs aimed at preventing the development of metabolic and chronic diseases, thereby enhancing overall health and quality of life. In addition, the results are anticipated to contribute to evidence-based public health policies and inform strategies for the prevention and management of chronic non-communicable diseases.

Enrollment: 120 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• adults aged 20 years and older
• overweight or obesity (BMI ≥25 kg/m²),
• stable body weight over the past 6 months
• physically inactive.

Exclusion criteria

• HbA1c >12%
• insulin therapy
• severe psychiatry and severe chronic illnesses of parents
• diseases of the hypothalamus and pituitary and adrenal gland
• mobility restriction
• tetraplegia
• use of obesity pharmacotherapy
• malignant disease and chemotherapy
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Group 1 (Physical Activity)

Experimental group

Description:

Adults aged 20 years and older with overweight or obesity (BMI ≥25 kg/m²), stable body weight over the past 6 months and be physically inactive.

Treatment:

Behavioral: Intervention of physical activity

Group 2 (Mediterranean Diet Education)

Experimental group

Description:

Adults aged 20 years and older with overweight or obesity (BMI ≥25 kg/m²), stable body weight over the past 6 months and be physically inactive.

Treatment:

Behavioral: Mediterranean Diet Education

Group 3 (Stress-Resilience Support)

Experimental group

Description:

Adults aged 20 years and older with overweight or obesity (BMI ≥25 kg/m²), stable body weight over the past 6 months and be physically inactive..

Treatment:

Behavioral: Stress-Resilience Training

Control Group

No Intervention group

Description:

Adults aged 20 years and older with overweight or obesity (BMI ≥25 kg/m²), stable body weight over the past 6 months and be physically inactive.